Anastomosis device approximating structure configurations

ABSTRACT

A surgical tool including an elongated body having a proximal end and a distal end, first and second sets of tissue approximating structures having deployed and retracted positions relative to the elongated body, an actuating mechanism at the proximal end of the elongated body for independently deploying and retracting each of the first and second sets of tissue approximating structures, and a drainage lumen extending from a drainage aperture at the distal end of the elongated body to the proximal end. The tool further includes a main balloon adjacent to the distal end of the elongated body, wherein the first set of tissue approximating structures has a different configuration than the second set of tissue approximating structures.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional application havingSer. No. 60/682,944, filed May 20, 2005, entitled “ANASTOMOSIS DEVICECONFIGURATIONS”, which application is incorporated herein by referencein its entirety.

TECHNICAL FIELD

The present invention relates to devices used for performing anastomosisand other related surgical procedures, including urethral proceduresthat involve reconnecting urethra and bladder tissues after a radicalprostatectomy, vesico-urethral anastomosis, and end-to-end urethralanastomosis.

BACKGROUND OF THE INVENTION

Anastomosis procedures are required for connecting or re-connectingcertain body tissues, such as in performing part of a surgicalprocedure. In particular, anastomosis procedures are used for joiningone hollow vessel or structure to another hollow vessel or structure sothat the interior portions of the vessel can communicate with eachother. In one type of procedure, which may be referred to as anend-to-end anastomosis, severed tissues of a first vessel are coupled,usually by suturing or stapling, to severed tissues of a second vessel.The tissues may be part of a body lumen such as a blood vessel,intestinal or other digestive system tissue, or tissues relating to theurinary system. As one example, in a radical prostatectomy, a surgeonremoves all or most of a patient's prostate. Because the urethra travelsthrough the prostate immediately before reaching the bladder, the upperpart of the urethra is also removed with the surgery. The procedureleaves a severed urethral stump and a severed bladder neck. To restoreproper urinary functions, the bladder and the urethra must bereconnected, which can be a relatively difficult and complex procedure.These difficulties can occur as a result of the tendency of the urethralstump to retract into adjacent tissue after being severed and also dueto the fact that the urethral stump is obscured by the pubic bone. Theseand other factors can make the area difficult to access by the surgeon,particularly for extended periods of time when performing the surgicalprocedure.

Conventionally, a surgeon may execute delicate suturing operations withtiny, fine needles to reconnect these or other anatomical bodies.However, installation of sutures with a needle to connect severedtissues within the body of a patient can be a difficult andtechnique-sensitive task. Many factors can make the task difficult,including a very small amount of tissue to work with (e.g., at theurethral stump and at the bladder neck), and proximal sensitive tissuessuch as ureters at a bladder and a proximal nerve bundle and sphincterat a urethral stump. These factors result in complicated and delicatesuturing procedures that, if not performed properly, could result incomplications such as leakage, difficulty in healing or failure to heal,or specific conditions such as incontinence or impotence.

To reduce the risks involved in conventional suturing procedures,anastomosis devices have been developed that include a drainage featureand tissue approximating structures that allow for reconnection oftissues without using traditional sutures. These anastomosis devicesadvantageously use tissue approximating structures to reconnect severedtissues during anastomosis procedures, which can both reduce the risksduring the surgical procedure and also provide a significant reductionin the amount of time required to perform certain anastomosisprocedures. These anastomosis devices include a balloon that is inflatedin the patient's bladder to keep the device in place during the healingprocess.

The tissue approximating structures can be activated by a number ofdifferent actuation mechanisms that the surgeon can use to extend andretract the tissue approximating structures relative to adjacent tissuestructures, as desired. These actuation mechanisms can advantageously beprovided to control tissue approximating structures that can take theform of at least one relatively sharp elongate structure (e.g., asharp-ended needle or tine) that can be extended from the elongated bodyof the device to contact and optionally penetrate into or through tissuefor approximation. However, because the tissue approximation structuresare often positioned adjacent to the balloon of the anastomosis device,there is a need to configure the anastomosis device so that theapproximation structures do not unintentionally come into contact withand/or damage the balloon.

SUMMARY OF THE INVENTION

Anastomosis devices and related surgical tools and external connectingdevices of the invention preferably include an elongated catheter body,tissue approximating structures that can extend and retract relative tothe elongated body, and actuating mechanisms for extending andretracting the tissue approximating structures. Examples of suchanastomosis devices are described, for example, in Applicants'co-pending United States Patent Applications having Ser. No. 10/646,383,filed Aug. 21, 2003, entitled “Anastomosis Device and Related Methods”;Ser. No. 10/919,545, filed Aug. 16, 2004, entitled “Anastomosis Deviceand Related Methods”; and Ser. No. 10/919,775 filed Aug. 16, 2004,entitled “Anastomosis Device and Related Methods”, all of which areincorporated herein by reference in their entireties. The anastomosisdevices also preferably include a drainage lumen that may extend as achannel through the length of the elongated body and that communicatesat its distal end with a drainage aperture, and a balloon at or adjacentto the distal end of the device. The concepts of the invention includedevices, configurations and positioning for tissue approximationstructures that minimize or eliminate contact between the approximationstructures and the balloon and/or any resulting damage to the balloon.

More specifically, the tissue approximating structures for theanastomosis devices of the invention can include two sets ofapproximating structures or tines spaced from each other along thelength of the catheter body that can be extended and retracted from thecatheter body. Each of the sets of tissue approximating structures maybe sequentially deployable in such a way that the surgeon can activate atissue approximation structure to engage a first tissue structure,verify that an adjacent second tissue structure is properly positionedrelative to the first tissue structure, then activate a second tissueapproximation structure to engage that adjacent second tissue structure.Each of the tissue approximation structures may be controlled by asingle actuation mechanism that is attached to the anastomosis deviceand is positioned outside the patient's body. The actuating mechanismsfor the tissue approximating structures are located generally near aproximal end of the device and are preferably connected to the tissueapproximating structures with at least one actuation wire, tube, lumen,or other mechanism. A separate actuation mechanism is preferablyprovided for each set of tissue approximating structures to allow forindependent extension and retraction of the tissue approximatingstructures, as desired. Alternatively multiple actuation mechanisms canbe connected to each other to provide a single actuation mechanism thatis manipulated to provide the desired movement of the tissueapproximating structures.

In one aspect of the invention, a surgical tool is provided whichcomprises an elongated body having a proximal end and a distal end,first and second sets of tissue approximating structures having deployedand retracted positions relative to the elongated body, an actuatingmechanism at the proximal end of the elongated body for independentlydeploying and retracting each of the first and second sets of tissueapproximating structures that have different configurations and adrainage lumen extending from a drainage aperture at the distal end ofthe elongated body to the proximal end. The surgical tool furtherincludes a main balloon adjacent to the distal end of the elongatedbody.

In one embodiment, distal ends of at least one of the tines of the firstset of tissue approximating structures is more sharp than at least oneof the distal ends of the tines of the second set of tissueapproximating structures, and the second set of tissue approximatingstructures can be closer than the first set of tissue approximatingstructures to the main balloon of the elongated body. The second set oftissue approximating structures may further include an enlarged portionat the distal end of at least one of its elongated tines, such as aball, a flap, or an elliptical portion. In another embodiment, at leastone of the first and second sets of tissue approximating structurescomprises at least one preshaped tine structure, wherein the set oftissue approximating structures comprising the at least one preshapedtine structure may be positioned closer than the other set of tissueapproximating structures to the main balloon. Each preshaped tinestructure may be made of a material having a memory that allows it to bein a deformed configuration when retracted and to be in a preshapedconfiguration when deployed.

In another aspect of the invention, a surgical tool is provided thatcomprises an elongated body having a proximal end, a distal end, and atleast one aperture extending through at least a portion of the body,first and second sets of tissue approximating structures having deployedand retracted positions relative to the elongated body, an actuatingmechanism at the proximal end of the elongated body for independentlydeploying and retracting each of the first and second sets of tissueapproximating structures, and a drainage lumen extending from a drainageaperture at the distal end of the elongated body to the proximal end.The tool further includes a main balloon adjacent to the distal end ofthe elongated body, and a second balloon spaced from the main balloontoward the proximal end of the elongated body, wherein the secondballoon has an expanded condition in which it diverts one of the firstand second tissue approximating structures from contacting the mainballoon. The main balloon and the second balloon may be independentlyexpandable. In addition, the second balloon can be positioned adjacentto the base of at least one tine of a set of tissue approximatingstructures such that expansion of the second balloon moves a portion ofeach of the tines radially away from the elongated body.

In yet another aspect of the invention, a surgical tool is provided thatcomprises an elongated body having a proximal end and a distal end,first and second tissue approximating structures having deployed andretracted positions relative to the elongated body, an actuatingmechanism at the proximal end of the elongated body for independentlydeploying and retracting each of the first and second sets of tissueapproximating structures, a drainage lumen extending from a drainageaperture at the distal end of the elongated body to the proximal end,and a main balloon adjacent to the distal end of the elongated body. Thefirst tissue approximating structure comprises a flexible material atleast partially surrounding the elongated body and extending along aportion of a length of the elongated body. The material of the firsttissue approximating structure can be slideable along the length of theelongated body and may comprise a mesh material.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be further explained with reference to the appendedFigures, wherein like structure is referred to by like numeralsthroughout the several views, and wherein:

FIG. 1 is a top view of an exemplary anastomosis device of the type thatcan be used with the various configurations of the invention;

FIG. 2 is a front view of a portion of an anastomosis device includingone embodiment of tissue approximating structures of the invention;

FIG. 3 is a front view of a portion of an anastomosis device includingpre-shaped tissue approximating structures;

FIG. 4 is a front view of a portion of an anastomosis device including asecondary inflatable portion;

FIG. 5 is a front view of a portion of an anastomosis device includingtissue approximating structures having enlarged tips;

FIG. 6 is an enlarged front view of a portion of the device of FIG. 5;

FIG. 7 is a perspective view of a portion of an anastomosis deviceincluding another embodiment of tissue approximating structures of theinvention;

FIG. 8 is a front view of the tissue approximating structure of FIG. 7in its retracted condition;

FIG. 9 is a front view of the tissue approximating structure of FIGS. 7and 8, with the tissue approximating structure in its deployedcondition;

FIG. 10 is a perspective view of a portion of an anastomosis deviceincluding one embodiment of tissue approximating structures that pivotrelative to the body of the device;

FIG. 11 is a front view of a portion of an anastomosis device having anextendible tissue approximating structure shown in its undeployedcondition;

FIG. 12 is a front view of the portion of the anastomosis device of FIG.11, with the extendible tissue approximating structure shown in itsdeployed condition;

FIG. 13 is a front view of a portion of an anastomosis device includinga hinged embodiment of tissue approximating structures;

FIG. 14 is a front view of a portion of an anastomosis device havingextendible tissue approximating structure shown in its deployedcondition; and

FIG. 15 is a front view of the portion of the anastomosis device of FIG.14, with the extendible tissue approximating structure shown in itsretracted or undeployed condition.

DETAILED DESCRIPTION

Referring now to the Figures, wherein the components are labeled withlike numerals throughout the several Figures, and initially to FIG. 1,an exemplary embodiment is shown of a modified-Foley-catheter-typeanastomosis device of the type that can be used with the variousconfigurations of the invention. Device 10 includes distal end 18,catheter body 12, balloon 14, and drainage aperture 16. Tissueapproximating structure can extend from catheter body 12, for example,along catheter body 12 adjacent to the balloon 14 near distal end 18.Tissue approximating structure of device 10 is shown as two sets oftines 32 (shown in an at least partially deployed condition) but mayalternatively include other structure or structures that may be used toplace or hold severed tissue in contact with another opposing severedtissue for healing, as will be described herein relative to certainaspects of the invention.

Device 10 further includes proximal end 20 opposite distal end 18. Inthe illustrated embodiment, proximal end 20 includes a port 24 that mayconnect to a lumen (not shown) such as an inflation lumen for balloon 14or a drainage lumen from aperture 16. Another port 26 can also be usedwith an inflation lumen or a drainage lumen. Device 10 further includesan actuating mechanism 30 for extending and retracting tines 32. Theactuating mechanism can comprise, for example, a turnable knob or alever that can be moved or rotated to extend or retract the tissueapproximating structure or tines 32. Other variations of these featuresof the illustrated proximal end will be understood by those of skill orare described herein relative to features of the invention, and/or maybe used in combination with the features of the invention. In accordancewith the invention, variations of several elements of an anastomosisdevice of the type generally described above relative to FIG. 1 aredescribed as follows relative to the remaining Figures. However, it isunderstood that the features, configurations, and methods describedbelow may be used with devices having a different configuration thanthat described relative to FIG. 1.

FIGS. 2-15 illustrate a variety of different configurations for thetines or tissue approximating structures of an anastomosis device. Anyof these configurations may be used alone or in conjunction with otherconfigurations of tines or tissue approximating structures within asingle anastomosis device. In particular, these configurations can beused to minimize the likelihood of unintentional interaction between thetissue approximating structures and the balloon. This can beaccomplished, for example, by providing more blunt surfaces that will beless likely to damage the balloon if they come in contact with theballoon (i.e., the surfaces minimize the possibility of undesiredinteraction with the balloon). However, the tissue approximatingstructures of the invention desirably should maintain the approximationfunction of the device at the bladder interface and/or protect theballoon from damage.

In addition, FIGS. 2-15 generally illustrate exemplary embodiments ofend portions of an anastomosis device in conjunction with various tissueapproximating structure configurations. These end portions are locatedgenerally at the distal end of an anastomosis device of the typedescribed above. Alternatively, the exemplary end portions andcorresponding tissue approximating structure of the invention may beused in a different type of device to perform anastomosis or othersurgical techniques that require deployment of structures such as tinesor tissue approximating structure, for example. Each of these endportions generally embodies the tip area of the device that is insertedinto a patient and is located at the opposite end of the anastomosisdevice from the portion of the device that will remain outside thepatient. Further, any device with which the tissue approximatingstructure of the invention is used may include an actuation mechanism,device, and/or structure that is used to manipulate the tissueapproximating structures when those structures are surgically positionedwithin a patient's body. The type of actuation mechanism used can varydepending on the input needed from the tissue approximating structure(e.g., linear or rotational movement, pressure, air, water, or thelike).

Referring to the embodiment of FIG. 2, an exemplary end portion 40 isshown that is located generally at the distal end of an anastomosisdevice of the type described above. End portion 40 includes a drainageaperture 42, a balloon or expanding portion 44, distal tissueapproximating structure 46, and proximal tissue approximating structure48. Distal tissue approximating structure 46 comprises a set ofrelatively flat and elongated tines or ribbons 50 having relativelyblunt distal ends 52, while proximal tissue approximating structure 48comprises a set of relatively narrow tines or wires 54 having ends 56that are relatively sharp in comparison to ends 52 of tines or ribbons50. For example, tines 54 may have a thin wire construction with sharpends that resemble a flexible needle or pin.

In order to provide the functionality of two sets of tissueapproximating structure along with added protection for balloon 44,balloon 44 is located closer to distal tissue approximating structure 46having the tines or ribbons 50 with blunt ends 52 than to the tines 54having sharper ends 56 (i.e., of proximal tissue approximating structure48). That is, the sharper set of tines 54 are spaced further fromballoon 44 to minimize the chances for its relatively sharper ends 56 tocome in contact with and possibly damage balloon 44 when it is inflatedor expanded. However, it is possible that the tissue approximatingstructure configurations are reversed such that the sharper set of tinesis closer to balloon 44, if desired, such as for a particular surgicalprocedure. It is further possible that both the distal and proximaltissue approximating structures comprise relatively flat and elongatedtines with blunt ends, such as the type illustrated as tines or ribbons50. In any case, any tines that are provided with blunt ends arepreferably sharp enough to be able to penetrate or otherwise reconnectsevered tissues in a patient, but are preferably dull or blunt enough todecrease the risk of puncturing the balloon or otherwise damagingcomponents and/or the patient.

It is noted that the tines described above and/or any of the othertissue approximation structures or tines described herein may be made ofa material such as nitinol, metal, plastic, or any other material thatis capable of being used in the human body (i.e., biocompatible) andthat provides both the desired strength and flexibility to the device.Further, the length of any tissue approximating structure shown in thefigures is only intended to be representative and the actual lengthsselected will depend upon the particular surgical techniques to beperformed, the material from which the tissue approximating structure ismanufactured, and other preferences or requirements for the tissueapproximation procedure. In addition, it is possible that all of thetines or extensions from a particular tissue approximating structure arenot identical to each other and that at least some of the tines within agroup of tines that make up a certain tissue approximating structure aredifferent from other tines within that group. For example, a distaltissue approximating structure on a single anastomosis device mayinclude tines with sharp ends and tines with blunt ends and/or mayinclude a number of other features of tissue approximating structuresthat are described herein or otherwise known relative to tissueapproximating structure configurations and options. In addition, thenumber of extensions, such as tines, that extend from the catheter bodycan be selected to include as few as one extension, or may have as manyextensions as desired to provide the desired performance of the tissueapproximation structures. Thus, while the description herein typicallyillustrates between approximately two and five extensions for aparticular tissue approximating structure, it is understood that thenumber of extensions can vary widely from this number, depending onrequirements of the surgical procedure to be performed.

FIG. 3 illustrates another embodiment of an end portion 60 that islocated generally at the distal end of an anastomosis device of the typedescribed above. End portion 60 includes a drainage aperture 62, aballoon or expanding portion 64, distal tissue approximating structure66, and proximal tissue approximating structure 68. Distal tissueapproximating structure 66 comprises a set of tines 70 that arepre-shaped or molded to have a memory that allows them to curl back onthemselves when not confined or otherwise straightened, preferably in adirection that prevents or limits them from contacting the balloon atany point before, during, or after the tissue approximation procedureoccurs. That is, the tines 70 preferably are capable of being at leastslightly deformed to accomplish a reconnecting of tissue and/or otherprocesses, but the memory feature of the material preferably directs theends of tines 70 away from balloon 64 when they are not otherwise beingdeformed or manipulated. Thus, the shapes of tines 70 can be selectedand designed so that they can penetrate or otherwise reconnect severedtissue in a patient, but are otherwise positioned so that its ends areat a low risk of puncturing the balloon or otherwise damaging componentsand/or the patient.

Proximal tissue approximating structure 68 comprises a set of tines 72that are relatively straight wire portions that may or may not becurved. The tines 70 and the tines 72 may be made of the same ordifferent materials. In order to provide the functionality of two setsof tissue approximating structure along with added protection forballoon 64, balloon 64 is located closer to distal tissue approximatingstructure 66 having shaped tines 70 than to proximal tissueapproximating structure 68 having tines 72. That is, the tines 72 arespaced further from balloon 64 than tines 70 that are designed with endsthat curl away from balloon 64. However, it is possible that the tissueapproximating structure configurations are reversed such that thestraight set of tines is closer to balloon 64, if desired, such as for aparticular surgical procedure. It is further possible that both thedistal and proximal tissue approximating structures 66, 68 comprisecurved tines.

FIG. 4 illustrates another exemplary embodiment of an end portion 80that is located generally at the distal end of an anastomosis device ofthe type described above. End portion 80 includes a drainage aperture82, a primary balloon or expanding portion 84 (which is shown in an atleast partially inflated or expanded condition in this figure), asecondary or auxiliary balloon 86 (which is also shown as being at leastpartially expanded or inflated in this figure), distal tissueapproximating structure in the form of tines 88, and proximal tissueapproximating structure 90. Secondary or auxiliary balloon 86 isprovided to help prevent or minimize the possibility of tines 88contacting or bending back against primary balloon 84 and therebydamaging balloon 84. Thus, secondary balloon 86 is preferably able to beinflated or expanded a sufficient amount to keep tines 88 fromcontacting balloon 84. The amount of inflation of secondary balloon 86can vary considerably depending on the chosen shape, size, and materialof tines 88. In devices where relatively large or long tines 88 areused, balloon 86 should be capable of being expanded to a larger sizethan the size that may be appropriate if relatively small or short tinesare used. Further, the distance that balloon 86 is spaced from balloon84 should also be selected so that inflation of balloon 86 does notinterfere with balloon 84 or the tissue reconnection process.

Balloon 84 and balloon 86 may be made of the same or different materialsand may be capable of being expanded or inflated to the same or adifferent size from each other. Balloon 84 and balloon 86 may beconnected to the same or different sources for inflation or expansion,which may be located at the proximal end of the anastomosis device. Ineither case, it is possible that balloons 84, 86 can be inflatableindependently from each other or that the inflation of one balloon 84,86 causes some proportional inflation of the other balloon 84, 86.Further, secondary balloon 86 is preferably positioned close enough tothe base of tines 88 that inflation of balloon 86 will cause the freeportion of tines 88 to move outward relative to their bases in arelatively uniform manner without puncturing balloon 86. Balloon 86 maybe provided with some type of limitation on its expansion so that itcannot expand to a size that allows it to interfere with the process ofreconnecting severed tissues in a patient, which may be accomplished byusing a material that is only expandable by a predetermined amount.Proximal tissue approximating structure 90 comprises a set of tines 92that are shown as relatively straight, needle-like structures. The tines88 and the tines 92 may be made of the same or different materials andmay or may not be configured similarly to each other.

Balloon 84 is located closer to secondary balloon 86 and tines 88 thanto tines 92 of tissue approximating structure 90. That is, the tines 92are spaced further from balloon 84 than the tines 88 that are moveableby secondary balloon 86. However, it is possible that the tissueapproximating structure configurations are reversed such that tines 92are closer to balloon 84, if desired, such as for a particular surgicalprocedure. It is further possible that more than one secondary balloon86 can be provided on a particular anastomosis device to divert orredirect a set of tines or other structures.

FIGS. 5 and 6 illustrate another embodiment of an end portion 100 thatis located generally at the distal end of an anastomosis device of thetype described above, where FIG. 6 is an enlarged view of tissueapproximating structure 106. End portion 100 of this embodiment includesa drainage aperture 102, a balloon or expanding portion 104, distaltissue approximating structure 106, and proximal tissue approximatingstructure 108. Distal tissue approximating structure 106 comprises a setof tines 110 that each include a wire or elongated portion 114 having anenlarged portion 112 at one end in the form of a ball, flap, or othershape. Enlarged portions 112 are provided to protect the balloon 104from being damaged by sharp tine ends. These enlarged portions 112 maybe preformed with their respective wire portion 114 and/or may bewelded, adhered, or otherwise secured to the wire 114. Each enlargedportion 112 may be considerably larger than the cross-sectional area ofthe wire 114 from which it extends, or may be only slightly larger.Further, enlarged portions 112 may have any desired shape that willprovide the function of protecting balloon 104, such as the cylindricalor elliptical shapes shown in the figures, or other desired shapes thatare at least slightly less sharp than the needle-like tine ends thatmight otherwise be provided.

Proximal tissue approximating structure 108 comprises a set ofrelatively narrow tines 116, which may have a wire-like configurationwith sharp ends. In order to provide the functionality of two sets oftissue approximating structure along with added protection for balloon104, balloon 104 is located closer to distal tissue approximatingstructure 106 having tines 110 with enlarged portions 112 than to tines116. However, it is possible that the tissue approximating structureconfigurations are reversed such that the sharper set of tines is closerto the balloon 104, if desired, such as for a particular surgicalprocedure. It is further possible that both the distal and proximaltissue approximating structures comprise at least one elongated wireportion having an enlarged end portion.

FIGS. 7-9 illustrate another configuration of a tissue approximatingstructure of the invention, including at least one set of extendingstructures that are relatively flexible, yet are strong enough to servetheir functional purpose of maintaining approximation of tissues. Inparticular, FIG. 7 illustrates an end portion 120 of an anastomosisdevice that generally includes a drainage aperture 122, a balloon orexpanding portion 124, distal tissue approximating structure 126, andproximal tissue approximating structure 128. Distal tissue approximatingstructure 126 comprises at least one flexible extension 130, each ofwhich extends through a corresponding slot or opening 132 in catheterbody 134. Extensions 130 are retractable and extendible relative to theopenings 132, as desired for use in reconnecting tissues. In thisembodiment, distal tissue approximating structure 126 includes multiple(e.g., four) extensions 130 attached at their proximal and distal endsto a moveable disk 136, as shown best in FIG. 8 (illustrating aretracted condition of extensions 130) and FIG. 9 (illustrating adeployed or extended condition of extensions 130). This structure 126 ispositioned within the interior portion of catheter body 134 when theanastomosis device is assembled. For clarity of the illustration, anyother structures that will be positioned within catheter body 134 arenot illustrated in FIG. 7, although an operating device would includeadditional lumens and the like within catheter body 134.

In its retracted condition shown in FIG. 8, tissue approximatingstructure 126 includes disks 136 that are spaced far enough from eachother that extensions 130 is generally straight. The outer surface ofdisks 136 are preferably sized to fit closely within the open centerarea of catheter body 134 so that the entire tissue approximatingstructure 126 can be contained within the walls of catheter body 134.When it is desired to deploy extensions 130 through corresponding slotsor openings 132, an actuation mechanism is used to force moveable disks136 closer to each other by moving either one or both of the disks 136toward the other of the disks 136. In this way, extensions 130 will bedeformed to bulge or extend outwardly from a centerline 137, as shown.In certain preferred orientations of tissue approximating structure 126within catheter body 134, extensions 130 will be aligned so that theyextend through slots or openings 132 when deployed. In fact, openings132 may dictate where extensions 130 can form in that the extensions 130will press on the inside of catheter body 134 until enough internalpressure causes extensions 130 to move out through openings 132. Thebent or curved end of extensions 130 provide blunt ends that arepreferably sharp enough to be able to penetrate or otherwise reconnectsevered tissues in a patient, but that are dull or blunt enough tominimize the risk of puncturing the balloon or otherwise damagingcomponents and/or the patient. It is possible, however, that extensionsare relatively sharp once configured in the manner shown in FIGS. 7 and9.

Proximal tissue approximating structure 128 comprises a set of tines 129that are generally narrow tines that have a structure that is similar toa wire. In order to provide the functionality of two sets of tissueapproximating structure along with added protection for balloon 124,balloon 124 is located closer to distal tissue approximating structure126 having flexible extensions 130 than to the tines 129. That is, tines129 are spaced further from balloon 124 to minimize the chances for itsends to come in contact with and possibly damage the balloon 124 when itis inflated or expanded. However, it is possible that the tissueapproximating structure configurations are reversed such that tines 129are closer to balloon 124, if desired, such as for a particular surgicalprocedure. It is further possible that both the distal and proximaltissue approximating structures are configured the same as the tissueapproximating structure 126.

FIG. 10 shows an end portion 140 of another exemplary anastomosis devicethat is similar to the embodiment illustrated in FIG. 7. That is, endportion 140 generally includes a drainage aperture 142, a balloon orexpanding portion 144, distal tissue approximating structure 146, andproximal tissue approximating structure 148. End portion 140 furtherincludes a catheter body 152 having at least one slot or recessed area154, which may be similar in configuration to the slots 132 of endportion 120 of FIG. 7. In the embodiment of FIG. 10, distal tissueapproximating structure 146 comprises at least one extension or paddle150, the number of which preferably corresponds with the number of slotsor recessed areas 154. Extensions 150 are retractable and extendibletoward and away from slots 154, respectively, as desired for use inreconnecting tissues. In particular, extensions 150 are able to pivotabout one end to allow for retraction and extension thereof relative tocatheter body 152. Extensions 150 are provided with relatively bluntends that are preferably able to penetrate, support, or otherwisereconnect severed tissues in a patient, but are preferably dull or bluntenough to decrease the risk of puncturing the balloon or otherwisedamaging components and/or the patient.

Proximal tissue approximating structure 148 comprises a set of tines 156that are generally narrow or thin tines that have a structure that issimilar to a wire. In order to minimize the chances for tissueapproximating structure to come in contact with and possibly damageballoon 144 when it is inflated or expanded, tines 156 are spaced to befurther from balloon 144 than the distance between balloon 144 anddistal tissue approximating structure 148 having retractable extensions150. However, it is possible that the tissue approximating structureconfigurations are reversed such that tines 156 are closer to theballoon 144, if desired, such as for a particular surgical procedure. Itis further possible that both the distal and proximal tissueapproximating structures are configured the same as the tissueapproximating structure 146.

FIGS. 11 and 12 illustrate another embodiment of an end portion 160 thatis located generally at the distal end of an anastomosis device of thetype described above. End portion 160 of this embodiment includes acatheter body 170 having a drainage aperture 162, a balloon or expandingportion 164, a braided structure 166, and proximal tissue approximatingstructure 168. Braided structure 166 includes an elongated mesh orbraided material that surrounds a portion of catheter body 170 betweenballoon 164 and proximal tissue approximating structure 168. Braidedstructure 166 extends along at least a portion of the length of catheterbody 170 between balloon 164 and proximal tissue approximating structure168. In its undeployed or retracted condition, shown in FIG. 11, a topedge 172 of structure 166 is positioned adjacent to balloon 164 and abottom edge 174 of structure 166 spaced from top edge 172 and ispositioned to optionally cover proximal tissue approximating structure168. As shown in FIG. 11, structure 166 in its undeployed condition isgenerally cylindrical in shape to closely match the outer surface ofcatheter body 170. In its deployed or extended condition, shown in FIG.12, bottom edge 174 has been moved upwardly toward top edge 172 so thatstructure 166 bulges outwardly to form a disk-like structure extendingfrom catheter body 170. In this position, proximal tissue approximatingstructure 168, which consists of at least one tine 176, is exposed suchthat any tine or tines 176 or other structures are available forreconnecting tissue. To form this disk-like configuration, either one orboth of the top edge 172 and bottom edge 174 can be moved toward theother of the edges in order to achieve the desired position of thestructure 166. However, it is contemplated that one of the edges 172,174 can be fixed or secured to catheter body 170, with the other of theedges 172,174 being moveable along the length of catheter body 170.

In any case, structure 166 will bulge or extend outwardly by an amountthat is proportional to or otherwise corresponds with the distancebetween edges 172, 174, which is controlled by an actuation mechanism.That is, the disk-like configuration of structure 166 will extendfurther from catheter body 170 as the edges 172, 174 are moved closer toeach other, which provides a manner of controlling a desired amount ofextension of the structure 166. When structure 166 is deployed, as inFIG. 12, the extended portion provides protection for balloon 164 frombeing damaged by sharp tine ends, such as from proximal tissueapproximating structure 168. Further, it is contemplated that structure166 is made of a material that is not braided or mesh-like, but is amore solid thin material, such as a tightly woven fabric or relativelythin plastic film, for example. However, it is desirable that thematerial or materials used for structure 166 have enough structuralintegrity to be able to be formed into and maintain the extended ringconfiguration shown in FIG. 12.

FIG. 13 illustrates another embodiment of an end portion 180 that islocated generally at the distal end of an anastomosis device. Endportion 180 of this embodiment includes a drainage aperture 182, aballoon or expanding portion 184, distal tissue approximating structure186, and proximal tissue approximating structure 188. Distal tissueapproximating structure 186 includes at least one flap 190 that isconnected at one end to a catheter body 194, and is connected to aconnector portion 192 at a point between its two ends. Each connectorportion 192 is connected to a slideable collar 195 at one end and toflap 190 at its other end. Collar 195 can be moved or slid along thelength of catheter body 194 to cause both flap 190 and connector portion192 to pivot relative to each other and relative to catheter body 194.This movement of the hinged structure can retract flap 190 towardcatheter body 194 and deploy or extend flap 190 away from catheter body194, as desired. Slots or openings may also be provided in catheter body194 to at least partially contain flaps 190 when in their retractedconfiguration.

Flaps 190 each have a free end 196 that can have a configuration thatwill provide the function of protecting balloon 184 from being damaged,although it is possible that ends 196 are relatively sharp. Proximaltissue approximating structure 188 comprises a set of relatively narrowor wire-like tines 198. In order to provide the functionality of twosets of tissue approximating structure along with added protection forballoon 184, balloon 184 is located closer to distal tissueapproximating structure 186 than to tines 198. However, it is possiblethat the tissue approximating structure configurations are reversed suchthat the sharper set of tines is closer to the balloon 184, if desired,such as for a particular surgical procedure. It is further possible thatboth the distal and proximal tissue approximating structures comprisehinged structures.

FIGS. 14 and 15 illustrate another embodiment of an end portion 200 thatis located generally at the distal end of an anastomosis device. Endportion 200 of this embodiment includes a drainage aperture 202, aballoon or expanding portion 204, distal tissue approximating structure206, and proximal tissue approximating structure 208. Distal tissueapproximating structure 206 includes a first end 212 adjacent to balloon204 and a second end 214 spaced further from balloon 204. In itsundeployed or retracted condition, shown in FIG. 15, distal tissueapproximating structure 206 is generally cylindrical in shape to closelymatch the outer surface of a catheter body 210. In its deployed orextended condition, shown in FIG. 14, second end 214 of tissueapproximating structure 206 is further from catheter body 210 than firstend 212, such as may be provided by expanding tissue approximatingstructure 206 by inflation. That is, structure 206 may be provided as abladder that is more free to expand at its second end 214 than its firstend 212, thereby providing the tapered shape to the structure 206.Alternatively, distal tissue approximating structure 206 may include anouter mesh or braided material that can be moved outwardly at its secondend 214 through the use of a bladder or some other structure that ispositioned between the outer material and the catheter body.

As shown in FIGS. 14 and 15, proximal tissue approximating structure 208is configured similarly to the distal tissue approximating structure206, however, the structure 208 is oppositely oriented along the lengthof catheter body 210 so that an end 216, which is closer to balloon 204than an end 218, is the end that can move outwardly relative to catheterbody 210 in a type of flare, such as through the use of a bladder orsome other structure that provides the tapered extension shown in FIG.14. It is understood that proximal tissue approximating structure 208 isoptional and that end portion 200 may instead be provided with onlydistal tissue approximating structure 206. In this case, another tissueapproximating structure configuration can be used for tissueapproximating structure 208.

The sequence of using anastomosis devices that include many of thetissue approximating structure variations described herein can besimilar, although the mechanisms used to deploy the structures can bedifferent. In general, tissue approximating structures can first beprovided to a surgeon in their undeployed or retracted positions withinthe attached catheter body. When it is desired to deploy the tissueapproximating structures, an actuation device or mechanism is activatedto either sequentially or simultaneously deploy one or more tissueapproximating structures. The actuation mechanisms may include a definedset of steps that are required for proper deployment of tissueapproximating structures, or the actuation may be achieved by a singlemovement or step. The retraction of the tissue approximating structurescan then be achieved by performing the opposite actions as were used fordeployment of the structures. The tissue approximating structures can bedeployed or retracted in a predefined sequence (e.g., bladder tines thenurethral tines) as desired for the surgical procedure.

The various embodiments described herein are not necessarily limited tomale-oriented or related surgical procedures and may be applied toeither gender and possibly to animals.

The present invention has now been described with reference to severalembodiments thereof. The foregoing detailed description and exampleshave been given for clarity of understanding only. No unnecessarylimitations are to be understood therefrom. It will be apparent to thoseskilled in the art that many changes can be made in the embodimentsdescribed without departing from the scope of the invention.

1. A surgical tool comprising: an elongated body having a proximal endand a distal end; first and second sets of tissue approximatingstructures having deployed and retracted positions relative to theelongated body; an actuating mechanism at the proximal end of theelongated body for independently deploying and retracting each of thefirst and second sets of tissue approximating structures; a drainagelumen extending from a drainage aperture at the distal end of theelongated body to the proximal end; and a main balloon adjacent to thedistal end of the elongated body; wherein the first set of tissueapproximating structures has a different configuration than the secondset of tissue approximating structures.
 2. The surgical tool of claim 1,wherein each of the first and second sets of tissue approximatingstructures includes at least one elongated tine having a distal end, andwherein the distal ends of at least one of the tines of the first set oftissue approximating structures is more sharp than at least one of thedistal ends of the tines of the second set of tissue approximatingstructures.
 3. The surgical tool of claim 2, wherein the second set oftissue approximating structures is closer than the first set of tissueapproximating structures to the main balloon of the elongated body. 4.The surgical tool of claim 2, wherein the second set of tissueapproximating structures comprises an enlarged portion at the distal endof at least one of its elongated tines.
 5. The surgical tool of claim 4,wherein the enlarged portion is one of a ball, a flap, and an ellipticalportion.
 6. The surgical tool of claim 1, wherein at least one of thefirst and second sets of tissue approximating structures comprises atleast one preshaped tine structure.
 7. The surgical tool of claim 6,wherein the set of tissue approximating structures comprising the atleast one preshaped tine structure is positioned closer to the mainballoon than the other set of tissue approximating structures.
 8. Thesurgical tool of claim 6, wherein each preshaped tine structure includesa distal end that is directed away from the main balloon.
 9. Thesurgical tool of claim 6, wherein each preshaped tine structure iscomprised of a material having a memory that causes the preshaped tinestructure to be in a deformed configuration when retracted and to be ina preshaped configuration when deployed.
 10. A surgical tool comprising:an elongated body having a proximal end, a distal end, and at least oneaperture extending through at least a portion of the body; first andsecond sets of tissue approximating structures having deployed andretracted positions relative to the elongated body; an actuatingmechanism at the proximal end of the elongated body for independentlydeploying and retracting each of the first and second sets of tissueapproximating structures; a drainage lumen extending from a drainageaperture at the distal end of the elongated body to the proximal end; amain balloon adjacent to the distal end of the elongated body; and asecond balloon spaced from the main balloon toward the proximal end ofthe elongated body, wherein the second balloon has an expanded conditionin which it diverts one of the first and second tissue approximatingstructures away from the main balloon.
 11. The surgical tool of claim10, wherein the main balloon and the second balloon are independentlyexpandable.
 12. The surgical tool of claim 10, wherein the second set oftissue approximating structures comprises at least one tine, and whereinthe second balloon is positioned adjacent to the base of the at leastone tine of the second set of tissue approximating structures such thatexpansion of the second balloon moves a portion of each of the tinesradially away from the elongated body.
 13. The surgical tool of claim 1,wherein the second tissue approximating structure includes at least oneextension that is pivotable toward and away from the elongated body. 14.The tool of claim 13, wherein the at least one pivotable extension ofthe second tissue approximating structure is hingedly connected to theelongated body.
 15. A surgical tool comprising: an elongated body havinga proximal end and a distal end; first and second tissue approximatingstructures having deployed and retracted positions relative to theelongated body; an actuating mechanism at the proximal end of theelongated body for independently deploying and retracting each of thefirst and second sets of tissue approximating structures; a drainagelumen extending from a drainage aperture at the distal end of theelongated body to the proximal end; and a main balloon adjacent to thedistal end of the elongated body; wherein the first tissue approximatingstructure comprises a flexible material at least partially surroundingthe elongated body and extending along a portion of a length of theelongated body.
 16. The surgical tool of claim 15, wherein the firsttissue approximating structure comprises a material that is slideablealong the length of the elongated body.
 17. The surgical tool of claim16, wherein the first tissue approximating structure has a first lengthwhen in a first position and a second length when in a second position,wherein the second length is shorter than the first length, and whereinthe first tissue approximating structure extends further radially fromthe elongated body when in the second position than when in the firstposition.
 18. The surgical tool of claim 16, wherein the first tissueapproximating structure comprises a mesh material.
 19. The surgical toolof claim 16, wherein the second tissue approximating structure comprisesa plurality of tines.
 20. The surgical tool of claim 17, wherein thesecond tissue approximating structure is at least partially covered bythe first tissue approximating structure when the first tissueapproximating structure is in the first position.
 21. The surgical toolof claim 15, wherein the second tissue approximating structure comprisesa flexible material at least partially surrounding the elongated bodyand extending along a portion of a length of the elongated body.
 22. Thesurgical tool of claim 21, wherein at least one of the first and secondtissue approximating structures has a fixed end secured to the elongatedbody and an opposite end that is radially moveable relative to theelongated body.
 23. The surgical tool of claim 22, wherein both thefirst and second tissue approximating structures have a fixed endsecured to the body and an opposite end that is radially moveablerelative to the elongated body.